The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:
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2 hour complimentary consultation
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Assistance with IRB and/or FDA Submissions
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Assistance with Protocol Development
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Creation of Regulatory Binder
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Assistance with Regulatory documents (i.e. 1572, Financial Disclosure, Site Signature, Delegation log, CV, Medical License, Laboratory certification, etc.)
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Serve as a liaison with study sponsor
Quick Links
- 21 CFR Part 11 Verification Statement (jpg)
- New Study Checklist – Industry Sponsored Study
- New Study Checklist – Investigator Initiated Study
- Non-Indemnified Clinical Trials
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Principal Investigator 101
PI 101 provides a foundational training specifically focused on operational and regulatory elements necessary for the ethical conduct of clinical research.
Other Resources
- Certificate of Confidentiality (COC)
- Clinical Trial Agreements (CTA)
- ClinicalTrials.gov (CT.gov)
- Confidential Disclosure Agreement (CDA)
- Conflict of Interest
- Institutional Biosafety Committee (IBC)
- Investigational Drug Service (IDS)
- Markey Cancer Center Clinical Research Office
- Office of Research Integrity (ORI)
- VA Research and Development
Learn more about the Regulatory Knowledge and Support Core. »
Contacts
William Stoops, PhD
- Director, Regulatory Knowledge and Support Core
- william.stoops@uky.edu
- (859) 257-5388
Ada Sue Selwitz, MS
- Co-Director, Regulatory Knowledge and Support Core
- ada.selwitz@uky.edu
- (859) 257-9454
